Medicare Policy at the Crossroads: Addressing Artificial Intelligence and Software

AdvaMed’s recent submission to the Food and Drug Administration (FDA) provides comments on the Agency’s revised draft guidance governing communications between drug and device manufacturers and payors, formulary committees, and similar entities.

Read Gateways to Health, a special publication exploring how medical technology improves patient care, expands access, and lowers healthcare costs.

WASHINGTON—Scott Whitaker, president and CEO of AdvaMed, the largest trade association representing medtech innovators, posted his statement on LinkedIn regarding the nomination of Chris Klomp as deputy secretary of the Department of Health and Human Services.

Millions of Americans have the neurological condition essential tremor. Often, that means their hand shakes so badly, they can’t hold a pen, fork, or glass of water. Every activity of daily living is compromised, day and night.

Millions of patients’ lives are improved every day because of advancements in medical technology. But too often, gaps in coverage and access prevent patients from benefiting from the safe, effective, and innovative technologies that can help detect disease earlier, improve treatment, and support better outcomes. 

That is why AdvaMed’s 2026 Patients First Agenda focuses on supporting policies that put patients at the center of health care. Across the country, AdvaMed works alongside patient advocacy group partners to help address gaps in access and coverage for critical medical technologies and bring innovative care to patients and families when they need it most.

Early Alzheimer’s blood tests are improving diagnosis, but access depends on policy. Learn how expanded Medicare coverage is changing patient outcomes.

The United States faces a maternal health crisis demanding urgent action. The U.S. has the worst maternal outcomes among high income nations. Our maternal mortality rates far exceed peer countries’, despite the highest per capita health care spending. Protecting mothers and improving birth outcomes provides an important opportunity for bipartisan priority leadership.

WASHINGTON—AdvaMed, the Medtech Association, the largest trade association representing medtech innovators, has long pressed for faster Medicare consideration of covering treatments using FDA-authorized breakthrough medtech. President and CEO Scott Whitaker made the following comment on a new initiative from FDA Commissioner Makary and CMS Administrator Oz on greater collaboration between the agencies to close the long gap — a median of nearly six years — between FDA authorization of breakthrough medtech and Medicare coverage. The new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway would “expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare,” according to FDA.